Exercise Training in Women With Heart Disease 2

NCT06494163 | Recruiting

• 1 other identifier: 20240363-01H
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effects of two different types of training on exercise capacity in women with coronary heart disease (CHD). Participants will be randomized into either the virtual high-intensity interval training (HIIT) or the virtual moderate-to-vigorous intensity continuous training (MICT). After randomization, patients will exercise twice a week, for 12 weeks. The sessions will be conducted virtually. Patients will undergo a maximal exercise test, cardiometabolic indicators (height (cm), body mass (kg), body composition (%), waist circumference (cm) and, resting blood pressure) and complete questionnaires about quality of life, mental health, self-determined motivation, self-efficacy and enjoyment.

Conditions

Cardiovascular Diseases; Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  will be measured using a gold standard symptom-limited, cardiopulmonary exercise test (CPET) on a treadmill (or on an alternate equipment, such as a cycle ergometer or recumbent bike). Gas exchange will be monitored continuously (- Parvo Medics TrueOne® 2400); the highest 20 second average rate of oxygen uptake achieved (i.e. peak VO2 in mL/kg/min) during the last minute of the CPET will represent exercise capacity.

  from baseline to week-6 and from baseline to week-12

Secondary Outcomes (13)

• physical and mental health

  from baseline to 12 weeks and baseline to 26 weeks

• Disease-specific Quality of Life, global health, physical and emotional health

  from baseline to 12 weeks and baseline to 26 weeks

• Anxiety symptoms

  from baseline to 12 weeks and baseline to 26 weeks

• Depressive symptoms

  from baseline to 12 weeks and baseline to 26 weeks

• body composition - BMI

  from baseline to 12 weeks and baseline to 26 weeks

Other Outcomes (5)

• Physical activity levels

  from baseline to 12 weeks and baseline to 26 weeks

• Program compliance

  from baseline to 12 weeks

• Participant Experience

  at 12 weeks

Study Arms (2)

standard care + moderate-intensity continuous exercise training

EXPERIMENTAL

2 days/week Warm-up: 60-70% peak HR - 10min Training: 70-85% peak HR - 35min Cool-down: 60-70% peak HR - 15min

Behavioral: Exercise

standard care + high-intensity interval training

EXPERIMENTAL

2 days/week Warm-up: 60-70% peak HR - 10min Training: 85-95% peak HR - 25 minutes (4x4-minutes of high-intensity intervals interspersed with 3 minutes of low-intensity intervals) Cool-down: 60-70% peak HR - 10min

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

The MICT and HIIT intervention groups will complete supervised virtual exercise sessions for 12 weeks using Zoom care or Microsoft Teams as a backup resource. The appointments will be scheduled and conducted 2 days per week. Initially, exercise intensity will be determined from participants' peak HR achieved during a baseline CPET.

standard care + high-intensity interval training; standard care + moderate-intensity continuous exercise training

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participants whose gender identity may differ from their birth-assigned sex (female) will be considered eligible for the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women (i.e., female sex assigned at birth) with CHD (e.g., coronary artery bypass grafting surgery \[CABG\], percutaneous coronary intervention \[PCI\], acute myocardial infarction \[MI\], MI with no obstructive coronary artery disease \[MINOCA\], or ischemia with no obstructive coronary artery disease \[INOCA\] at least 4 weeks post procedure or event; based on clinical evidence this is a safe period of time to exercise);
• Patient is able to perform a symptom limited CPET (this is the primary outcome and needed to determine peak HR for the exercise training prescription); and
• Patient is able to read and understand English or French.

You may not qualify if:

• Patient is currently participating in routine exercise training (\>2x/week, routine exercise training is defined as a planned, structured, and repetitive exercise that is performed in order to maintain or improve physical fitness.) (this may reduce the impact of HIIT or MICT on outcomes);
• Patient has: NYHA class III-IV heart failure symptoms; unstable angina; or established diagnosis of chronic obstructive pulmonary disease, severe mitral or aortic stenosis, or hypertrophic obstructive cardiomyopathy (this may interfere with the ability to engage in MICT or HIIT);
• Patient has uncontrolled arrhythmia (this may impact the HR-based exercise training prescription and monitoring);
• Patient is unable to provide written informed consent; or
• Patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks.
• Patient is unwilling to be randomized to HIIT or MICT.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Reed, PhD

CONTACT

613-696-7392; jreed@ottawaheart.ca

Matheus Mistura, MSc

CONTACT

6136967000; mmistura@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: March 11, 2026

Record last verified: 2025-08

Locations

CA (1)